At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 122 enrolled
Drug / intervention
Asenapinedrug
Likely dose
Asenapine 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.
In Brief
A Phase 3 clinical trial evaluating Asenapine for Psychosis. Completed, enrolled 122 participants.
Detailed Summary
This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsychosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2006
Enrollment StartFeb 2006
Primary CompletionDec 2008
TodayJul 2026
First PostedJan 24, 2006
Enrollment StartFeb 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.4 years ago
Interventions
Asenapinedrug
Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).